Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug is now approved for use in treating adult patients with active ankylosing spondylitis (AS) who have had poor efficacy or intolerance to one or more TNF inhibitors.
Clinical Trial Basis
The NMPA’s approval is based on results from the multicenter, randomized, double-blinded, placebo-controlled adaptive seamless Phase II/III SHR0302-302 study. This trial demonstrated ivarmacitinib’s good efficacy and safety in patients with AS, highlighting its potential as a valuable treatment option for this patient population.
Future Applications
Ivarmacitinib is also under review by the NMPA for additional indications, including atopic dermatitis, rheumatoid arthritis, and alopecia areata. These potential expansions underscore the broad therapeutic potential of ivarmacitinib and Hengrui’s commitment to addressing unmet medical needs in autoimmune diseases.-Fineline Info & Tech
Leave a Reply